Cleared Traditional

K024258 - NEUROTECH KNEEHAB

K024258 is the FDA 510(k) clearance for NEUROTECH KNEEHAB by Bio-Medical Research, Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 802-day FDA review.

K024258 · Bio-Medical Research, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
802d
Days
Class 2
Risk

K024258 is an FDA 510(k) clearance for the NEUROTECH KNEEHAB. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on March 4, 2005 after a review of 802 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number K024258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date March 04, 2005
Days to Decision 802 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
687d slower than avg
Panel avg: 115d · This submission: 802d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 135
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